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Atebrioz (zilurgisertib)

Fibrodysplasia ossificans progressiva

Also known as INCB000928
Regulatory submission
NDA submitted by May 2026
Last updated
96 sources

Product information and disease descriptionProduct descriptionProduct information

Indication

3 evidence topics · 1 source

Approved indication

“ATEBRIOZ is indicated to reduce the volume of total new heterotopic ossification (HO) in adults and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva (FOP).” (opens the prescribing information at this quote)

Definition of total new heterotopic ossification volume in the label

“Efficacy was established based on the effect of ATEBRIOZ on total new HO lesion volume (assessed by whole-body computed tomography [WBCT], excluding the head) compared to placebo during the double-blind period. Total new HO lesion volume includes expansion of baseline HO lesion burden as well as any new discrete HO that developed during the 24-week” (opens the prescribing information at this quote)

Age limit of the indication

“The safety and effectiveness of ATEBRIOZ have not been established in pediatric patients younger than 12 years of age.” (opens the prescribing information at this quote)